Abstract This study assesses the clinical performance of three anti‐SARS‐CoV‐2 assays, namely EUROIMMUN anti‐SARS‐CoV‐2 nucleocapsid (IgG) ELISA, Elecsys anti‐SARS‐CoV‐2 nucleocapsid (total antibodies) assay, and LIAISON anti‐SARS‐CoV‐2 spike proteins S1 and S2 (IgG) assay. One hundred and thirty‐seven coronavirus disease 2019 (COVID‐19) samples from 96 reverse‐transcription polymerase chain reaction confirmed patients were chosen to perform the sensitivity analysis. Non‐SARS‐CoV‐2 sera ( n = 141) with a potential cross‐reaction to SARS‐CoV‐2 immunoassays were included in the specificity analysis. None of these tests demonstrated a sufficiently high clinical sensitivity to diagnose acute infection. Fourteen days since symptom onset, we did not find any significant difference between the three techniques in terms of sensitivities. However, Elecsys performed better in terms of specificity. All three anti‐SARS‐CoV‐2 assays had equivalent sensitivities 14 days from symptom onset to diagnose past‐COVID‐19 infection. We also confirmed that anti‐SARS‐CoV‐2 determination before Day 14 is of less clinical interest.
【저자키워드】 COVID‐19, serology, SARS‐CoV‐2, cut‐off, symptom onset, 【초록키워드】 coronavirus disease, IgG, Infection, ELISA, Spike protein, COVID‐19, SARS‐CoV‐2, immunoassay, sensitivity, specificity, nucleocapsid, acute infection, sera, Patient, sensitivity analysis, Euroimmun, diagnose, Analysis, clinical sensitivity, LIAISON, significant difference, sensitivities, total antibodies, polymerase chain, S1 and S2, performed, assays, Day, less, demonstrated, Elecsy, 【제목키워드】 Spike protein, immunoassay, nucleocapsid, clinical, automated,